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Manufacturers seek clear path to develop safe-use approaches for more risky OTC therapies.
The prospect that consumers will improve their health through wider use of nonprescription drugs is back on the policy agenda at FDA. Pharmacists, healthcare companies, and some consumer groups are backing the agency's new campaign to authorize certain over-the-counter (OTC) drugs with special "conditions for safe use," such as access to electronic information and special assistance from pharmacists. Whereas OTC medicines primarily treat acute, short-term conditions, FDA officials are touting this "new paradigm" as a way to approve nonprescription meds for common chronic diseases, with the help of systems that assist patients in assessing their health and response to medication over longer terms.
FDA is considering whether "there should be more flexibility in the concept of nonprescription drugs," explained Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), during a two-day public hearing held in March by FDA to gain stakeholder input on the proposal. To approve an OTC therapy, FDA currently seeks evidence from manufacturers that the medicine can be used safely and appropriately based on the approved "drugs facts box" label and common knowledge. Now, FDA is exploring whether additional information from pharmacists and health IT systems could sufficiently augment consumer understanding of how to select and use a drug appropriately without going to a doctor.
Such a change, Woodcock acknowledged, will require a lengthy rule-making process; legislation also is needed for FDA to permit simultaneous marketing of both prescription and nonprescription versions of the same drug. Manufacturers could implement "safe use" provisions voluntarily, but would be disadvantaged because FDA cannot compel competitors to adopt procedures not listed on the product label. There is talk of including authorizing language for this approach in this year's user-fee renewal legislation, but the desire to avoid any proposals that could delay Congressional action is likely to put the topic aside for the short term.
The rationale for expanded OTC drug access is that the cost and inconvenience of visiting a doctor to obtain a prescription deters many people from treating common health conditions—and from adherence to recommended therapy after treatment begins. There's strong evidence from the literature over the past 20 years that prescription-to-OTC switches for vaginal antifungals, allergy treatments, and heartburn medicines, among others, have promoted effective self-care. Testing innovative nonprescription products has improved methods for conducting label-comprehension studies and actual-use trials as well.
Yet, Merck failed several times to gain OTC status for its anticholesterol drug Mevacor (lovastatin), largely because FDA was not convinced that consumers could determine whether a cholesterol drug was right for them just by reading the product label. FDA has tried to handle with such situations by establishing a third category of "behind-the-counter" drugs available from pharmacists, as with the Plan B morning-after pill. However, manufacturers generally object to creating a third class of drugs or simultaneous marketing of a prescription and nonprescription product for fear that such options will confuse consumers.
Under FDA's new paradigm, manufacturers would ensure "safe use" of a medicine by using new IT programs and more home-use diagnostics to enhance and document individual understanding of appropriate drug use. Information kiosks and other IT aides in pharmacies, for example, could direct consumers through self-diagnosis information programs that check for risk factors contraindicating treatment and monitor continued safe use.
The most vocal opposition to more flexible nonprescription drug regulation comes from the American Medical Association (AMA). Doctors may be concerned about poor medication adherence, but insist that physician involvement in patient care and treatment is vital, especially for patients with chronic diseases, said Sandra Fryhofer, chair-elect to the AMA Council on Science and Public Health, at the FDA public hearing. Emergency pharmacy access to Epi-Pens might be appropriate, but "FDA has not offered evidence that patients with hypertension, hyperlipidemia, asthma or migraine headaches can self-diagnose and mange those serious chronic medical conditions safely on their own."
Fryhofer further warned that wider use of OTC drugs probably could raise out-of-pocket costs for individuals that have health insurance, and that change alone could create "a new barrier to adherence." Although OTC medicines reduce overall healthcare spending by $102 billion a year, according to the Consumer Healthcare Products Association (CHPA), individuals could end up paying more because insurers, employers, and government healthcare programs seldom reimburse for nonprescription medicines. That situation could change, however, if healthcare plans decide to cover third-class medicines in certain cases. In addition, patient outlays for OTCs would be offset in part by eliminating the need for doctor visits.
Pharmaceutical manufacturers could benefit from increased sales of nonprescription products, but are keeping fairly quiet about these prospects, particularly about the role of switches in retaining market share for a brand facing competition from generic or other new therapies.
At the FDA meeting, CHPA President Scott Melville highlighted how OTC medicines save billions of dollars for the healthcare system overall and provide relief to millions of Americans. Melville also urged retaining a "clear distinction" between prescription and nonprescription drugs, and that FDA should approve OTCs under its proposed paradigm individually and based on scientific data. Generic-drug makers support OTCs in general, but not necessarily switches that make it harder to enter a market; barriers could emerge if FDA approves an OTC with safe-use provisions that apply to all similar products.
Drug distributors also are uneasy about OTCs with special conditions for safe use that limit product distribution to certain pharmacies or retail outlets. The Healthcare Distribution Management Association urged FDA to adopt standardized processes for requiring distributors to determine which pharmacies and customers may receive a particular nonprescription drug.
Pharmacists are most enthusiastic about FDA's new paradigm as a way to "optimize the important role pharmacists can play in improving public health," said Thomas Menighan, CEO of the American Pharmacists Association. He and others cited pharmacists' success in administering vaccines to millions of individuals and in forming collaborative practice agreements with local physicians to check blood pressure and order tests related to specific medication management programs. They also point to "rescue medicines," such as asthma inhalers and epinephrine to block allergic reactions, as ready candidates for enhanced pharmacy access.
However, pharmacists emphasize that they will need additional compensation for providing extra clinical services as part of safe use conditions. FDA is not likely to require specific payments, but Menighan advised that agency policies should not preclude reimbursement by the patient, third parties, states, Medicare, or sponsors.
At the same time, retail pharmacists prefer to limit expanded access programs to bonafide pharmacies, as opposed to the thousands of retail outlets that sell OTC medicines. And pharmacists working in hospitals and for healthcare systems have expressed that they are well-positioned to participate in special safe-use programs
Not surprising, IT and research firms are eager to provide a range of technology to support these efforts. They are proposing new ways to evaluate and ensure compliance with self-diagnostic tools, to devise collaborative programs that enhance care management, and to coordinate follow-up and oversight in collaboration with physicians, payers, and patients. Manufacturers also are exploring such systems, such as testing by GlaxoSmithKline Consumer Healthcare of an interactive drug facts kiosk to help consumers self-determine the need for and suitability of using statins to reduce cholesterol. The program, explained GSK Vice-President David Schifkovitz, could run on a home computer or smart phone and produce a personal recommendation regarding treatment.
An interesting side issue to the debate is whether enhanced access to medicines without a prescription could defuse the current hostilities over contraception coverage. A number of women's health organizations applauded FDA's paradigm at the hearing as a way to promote "reproductive freedom" for women by facilitating access to safe and effective birth control methods. Eleanor Schwarz, director of the Center for Research on Health Care, described studies showing that women can use an IT kiosk to perform self-screening for Chlamydia and for oral contraceptive. Given that most healthcare plans do not pay for nonprescription medicines, access to OTC oral contraceptives makes moot the debate over whether religious-affiliated organizations should reimburse for birth control pills. Of course, any move by FDA to authorize nonprescription contraceptives would launch a wave of objections from physicians and family planning opponents—similar to what happened last December when FDA proposed to drop OTC limitations for Plan B.
To move forward with this initiative, policymakers need to devise appropriate exclusivity arrangements and other incentives for manufacturers to invest in innovative information and patient monitoring systems. In addition, methods for testing the efficacy of patient self-selection programs need to be validated. Despite these and other obstacles, Woodcock and others appear optimistic that this new approach not only could enhance medication use, but also identify drug–drug interactions and improve pharmacovigilance tracking. Although efforts to expand nonprescription drug use in the past have failed, the advent of electronic medical records and smart phones may create a more positive atmosphere for change.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, firstname.lastname@example.org .